1. Field of the Invention
The present invention relates to ear curettes, more particularly, the present invention relates to disposable ear curettes with specialized tip configurations and incorporating a depth measurement system.
2. Background Information
Cerumen, commonly called ear wax, is produced in the outer third of the cartilaginous portion of the human ear canal. It is a mixture of viscous secretions from sebaceous glands and less-viscous ones from modified apocrine sweat glands. The primary components of cerumen have been identified as comprising shed layers of skin, with 60% of the cerumen consisting of keratin, 12-20% saturated and unsaturated long-chain fatty acids, alcohols, squalene and 6-9% cholesterol.
There are two distinct genetically determined types of cerumen: the wet type, which is dominant, and the dry type, which is recessive. While Asians and Native Americans have been identified as more likely to have the dry type of cerumen (gray and flaky), and Caucasian and Blacks have been listed as being more likely to have the wet type (honey-brown to dark-brown and moist).
The American Academy of Otolaryngology discourages earwax removal unless excess earwax is causing health problems. A number of softeners are effective; however, and another common method of cerumen removal is syringing or irrigation with warm water. Finally, a curette based method is often used by otolaryngologists when the ear canal is partially occluded and the material is not adhering to the skin of the ear canal.
Cerumen removal utilizing an ear curette has been estimated to be performed approximately 22 million times annually with the number expected to grow as the baby boomer generation ages.
Numerous ear curette designs have been proposed over the years.
Although not an ear curette per se, a 1975 development shown in U.S. Pat. No. 4,027,658 shows a sample taking instrument comprising handle portion and an operative tip extending from one end of the handle portion with the tip including an elongated cylindrical end with longitudinal and circumferential grooves therein.
A 1981 design is shown in U.S. Pat. No. D275,127 and comprises a polygonal in cross-section handle portion (which prevents instrument rolling on an instrument tray) and an operative tip extending from one end of the handle portion with the tip including an annular open circular scraping ring.
A 1988 design is shown in U.S. Pat. No. D318,117 and comprises a distal handle portion and an operative tip extending from one end of the handle portion with the tip including an annular open circular scraping ring.
A 1992 design is shown in U.S. Pat. No. 5,348,023 and comprises a distal handle portion and an operative tip extending from one end of the handle portion with the tip including a closed spoon type scraping member.
A 1994 design is shown in U.S. Pat. No. D368,520 and comprises a central handle portion and a first operative tip extending from one end of the handle portion with the first tip including an open circular shaped scraping member extending along the axis of the handle and having opposed scraping surfaces of distinct diameters. A second opposed end includes a ball with no known curette function.
A 1994 design is shown in U.S. Pat. No. 5,632,756 and comprises a handle portion and an operative tip extending from one end of the handle portion with the tip including a “bulbous banded cage” scraping member.
A 1995 design is shown in U.S. Pat. No. D372,311 and comprises a handle portion and an operative tip extending from one end of the handle portion with the tip including an annular closed oval scraping ring and the device further including a suction or irrigation tube extending to the scraping ring.
A 1995 design is shown in U.S. Pat. No. D381,426 and comprises a handle portion and an operative tip extending from one end of the handle portion with the tip including an annular closed oval scraping ring extending at an oblique angle relative to the handle.
A 1995 design is shown in U.S. Pat. No. 5,586,989 and comprises a handle portion with an offset and an operative tip extending from the offset end of the handle portion with the tip including an annular closed oval scraping ring extending at an oblique angle relative to the tip and handle.
A 1996 design is shown in U.S. Pat. No. 5,715,850 and comprises a handle portion with an operative tip extending from the end of the handle portion with the tip including one of a series of scraping members at an end thereof. The scraping members disclosed include a series of wire looped designs of FIGS. 2 and 3a, 3b and 3c, a wire spiral design of FIG. 3d, and four longitudinally extending radial scraping edges in FIG. 3e. 
A 1997 design is shown in U.S. Pat. No. D393,312 and comprises a handle portion and an operative tip extending from one end of the handle portion with the tip including an open oval shaped scraping member extending along the axis of the handle.
Two 1997 designs shown in U.S. Pat. Nos. D415,275 and D420,133 each comprises a handle portion and an operative tip extending from one end of the handle portion with the tip including an closed spoon type scraping member extending along the axis of the handle.
A 1998 design is shown in U.S. Pat. No. D428,489 and comprises a handle portion and an operative tip extending from one end of the handle portion with the tip including an open circular shaped scraping member extending at an oblique angle relative to the axis of the handle.
A 1998 design is shown in U.S. Pat. No. D445,503 and comprises a handle portion and an operative tip extending from one end of the handle portion with the tip including an open expanding oval or tear-dropped shaped scraping member extending along the axis of the handle.
A 1999 design is shown in U.S. Pat. No. D423,669 and comprises a central handle portion and a first operative tip extending from one end of the handle portion with the first tip including an open circular shaped scraping member extending along the axis of the handle, and a second operative tip extending from an opposed end of the handle portion with the second tip including a closed spoon type scraping member.
A 1999 design is shown in U.S. Pat. No. D439,338 and comprises a handle portion and an operative tip extending from one end of the handle portion with the tip including an open tear-dropped shaped scraping member extending along the axis of the handle.
A 2001 design is shown in U.S. Pat. No. D449,888 and comprises a handle portion and an operative tip extending from one end of the handle portion with the tip including an open trapezoidal shaped scraping member curving away from the axis of the handle.
A 2001 design is shown in U.S. Pat. No. D450,676 and comprises a handle portion and an operative tip extending from one end of the handle portion with the tip including an open trapezoidal shaped scraping member curving away from the axis of the handle.
A 2005 design is shown in U.S. Pat. No. D539,426 and comprises an ergonomic central handle portion configured for a pair of operative tips extending from each end of the handle portion with each tip including an open circular shaped scraping member extending at an angle relative to the axis of the handle.
A 2009 design is shown in U.S. Published Patent Application No. 2010-0042122 and comprises a central triangular handle portion configured for a pair of operative tips extending from each end of the handle portion with each tip including an open circular shaped scraping member extending at an angle relative to the axis of the handle, or solid trapezoidal shaped scraping members.
The above mentioned patents and published patent applications are incorporated herein by reference and provide an overview of the ear curette art. The above prior art designs fails to provide an ear curette tool that is easily accommodated to removal of the two distinct types of cerumen, i.e. the wet type and the dry type. If the ear curette utilized by the professional in the cerumen removal is not adequate for the type of cerumen encountered then there is an increased likelihood of additional trauma to the patient, increase in the length of the procedure, increase in the technical difficulty in performing the procedure by the health care professional, and an increase in the likelihood of subsequent procedures (e.g., softeners with extended or repeated irrigation).
Additionally the administration of health care is increasing the issues encountered with this cerumen removal medical procedure. For example some medical billing codes will distinguish between an instrument based cerumen removal such as with a curette (for cerumen which is considered clinically “impacted” this is classified as a surgical procedure) and a non-instrument based cerumen removal process such as a lavage that may be performed by a nurse. This distinction in classification and whether or not it is a surgical procedure has resulted in a demand for greater documentation of the surgical procedure, such as detailing the reasons for impaction. This move to greater documentation for the surgical curette based procedures is now including a description of the depth within the ear of the impacted cerumen being removed.
There is no current system for health care professionals in a cerumen removal for easily objectively quantifying the depth within the ear of the impacted cerumen being removed. Without such system the health care professionals will merely estimate the depth within the ear of the impacted cerumen being removed resulting in non-objective and non-verifiable documentation.
It is an object of the present invention to minimize the drawbacks of the existing ear curettes and to provide a simple, cost effective, efficient and safe ear curette that can be utilized for both types of cerumen and which provide a depth measurement system for objective measurement by the users.